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Bypass electrodes Ag/AgCl
EUDAMEDFDA UDIClass I (EU MDR)
Ref BYP10Model ELECUP120
by Pamel d.o.o.
Identity
- Trade Name
- Bypass electrodes Ag/AgCl EUDAMEDCOMBY EEG CAP FDA UDI
- Generic Name
- Analytical scalp electrode, reusable FDA UDI
- Device Name
- electrodes CUP 120cm with sintered Ag/AgCl electrodes EUDAMEDBypass electrodes Ag/AgCl FDA UDI
- Model / Reference
- ELECUP120 EUDAMEDBYP10 EUDAMEDBypass electrodes Ag/AgCl FDA UDI
- Description
- Bypass electrodes Ag/AgCl FDA UDI
Identifiers
- Catalog Number
- BYP10 FDA UDI
- Primary DI / UDI-DI
- 03858894153398 EUDAMEDFDA UDI
- Basic UDI-DI
- 385889415EEGELECTRODESHC EUDAMED
- 510(k) Number
- K211315 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
- GMDN Term
- Analytical scalp electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Croatia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bypass electrodes Ag/AgCl by PAMEL d.o.o. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 385889415EEGELECTRODESHC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pamel d.o.o.
- EUDAMED SRN
- HR-MF-000028336
Sources (2)
- EUDAMED 30dac440-afbd-4d6f-a78e-12eb435abe7f 61 fields · synced Jun 17, 2026
- FDA UDI 238d0e25-1f2c-453e-a759-490c01b70916 36 fields · synced May 30, 2026